Safety and Effectiveness of PEG-Intron in HIV-Infected Patients

NCT ID: NCT00005012

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2000-09-30

Brief Summary

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The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).

Detailed Description

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At entry, patients undergo HIV genotypic/phenotypic analysis. Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotyping/phenotyping are available (approximately 4 weeks). Patients who respond with a 0.5 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study.

Conditions

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HIV Infections

Keywords

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Interferon Alfa-2b Lymphocyte Transformation CD4 Lymphocyte Count RNA, Viral Virus Inhibitors Anti-HIV Agents Viral Load

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Peginterferon alfa-2b

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients may be eligible for this study if they:

* Have HIV levels of more than 2000 copies/ml.
* Have failed their current HAART (had a significant increase in their HIV levels with HAART).
* Have a CD4 cell count greater than 200 cells/microL.
* Have had more than 6 months of HAART.
* Have been on their current HAART for at least 6 weeks.
* Agree to use an effective method of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history of a serious mental disorder.
* Are allergic to interferons.
* Are pregnant or breast-feeding.
* Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role lead

Locations

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East Bay AIDS Ctr

Berkeley, California, United States

Site Status

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Dupont Circle Physicians Group

Washington D.C., District of Columbia, United States

Site Status

IDC Research Initiative

Altamonte Springs, Florida, United States

Site Status

Duval County Health Department

Jacksonville, Florida, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Infectious Diseases Associates

Sarasota, Florida, United States

Site Status

Piedmont Physicians at Vinings

Atlanta, Georgia, United States

Site Status

TRIAD Health Practice

Chicago, Illinois, United States

Site Status

Univ of Maryland Institute of Human Virology

Baltimore, Maryland, United States

Site Status

New England Med Ctr / Div of Geo Med & Infect Disease

Boston, Massachusetts, United States

Site Status

Regions Hosp

Saint Paul, Minnesota, United States

Site Status

Washington Univ

St Louis, Missouri, United States

Site Status

Southwestern New Jersey AIDS Clinical Trials

Camden, New Jersey, United States

Site Status

East Orange Veterans Administration Med Ctr

East Orange, New Jersey, United States

Site Status

Beth Israel Med Ctr

New York, New York, United States

Site Status

Univ Hosps of Cleveland

Cleveland, Ohio, United States

Site Status

MCP Hahnemann Univ

Philadelphia, Pennsylvania, United States

Site Status

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

Site Status

Amelia Ct Clinic

Dallas, Texas, United States

Site Status

Joseph C Gathe

Houston, Texas, United States

Site Status

San Juan VAMC

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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P00737

Identifier Type: -

Identifier Source: secondary_id

B010

Identifier Type: -

Identifier Source: org_study_id